Morphotek Announces Acceptance of Investigational New Drug Application for MORAb-003, a humanized monoclonal antibody for the treatment of advanced ovarian cancer
Exton, PA, March 28, 2005– Morphotek, Inc. today announced that the United States Food and Drug Administration has accepted its Investigational New Drug (IND) Application for treatment of advanced ovarian cancer with MORAb-003, a humanized monoclonal antibody. The Phase I clinical study is designed as an open label single dose escalation safety study in patients with chemo-refractive ovarian cancer.
MORAb-003 is a monoclonal antibody that has high specificity for a number of different cancers, including ovarian, breast, colorectal, lung, renal, and brain. In pre-clinical cancer models the antibody has demonstrated that it can efficiently kill chemo-refractory tumors and suppress growth in xenograft studies.
“An unmet medical need exists for patients with advanced, chemo-refractory ovarian cancer,” stated Nicholas Nicolaides, President and Chief Executive Officer. “In pre-clinical studies MORAb-003 has been shown to be active against chemo-refractory ovarian tumors. The antibody targets a receptor present at high density on cancer cells, and offers a very high degree of specificity for malignant tissues. We look forward to updating the progress of this antibody as it advances through clinical trials.”
“This is the first of several antibodies in our product portfolio that the company plans on advancing into clinical development for cancer, inflammation and infectious diseases,” added Philip M. Sass, Executive Vice President and Chief Operating Officer of Morphotek. We are in the late stages of development for a second monoclonal antibody, MORAb-009, which is an antibody that targets a high percentage of pancreatic cancers and other difficult to treat malignancies. We will file an IND by the end of this year.”
Ovarian cancer ranks fourth in cancer deaths among women, accounting for more deaths than any other cancer of the reproductive system (American Cancer Society). In 2005, it is estimated that there will be 22,220 new cases of ovarian cancer in the U.S. and approximately 16,000 women will die from the disease. Worldwide, more than 182,000 new patients will be diagnosed with this form of cancer (World Health Organization).
Morphotek®, Inc. is a biotechnology company focused on the generation of proprietary organisms for product discovery and development. The Company has a validated and patented platform technology called morphogenics that rapidly enhances the natural process of genetic evolution within a targeted host to yield variants with novel, commercially important output traits. This versatile technology has been successfully applied to microbes, plants, and mammals to yield genetically diverse offspring that are suitable for pharmaceutical and agricultural product development in the areas of antibody and protein therapeutics, high-titer protein manufacturing, and drug target discovery. Morphotek is also marketing an exciting new antibody platform for developing high-quality, fully human therapeutic antibodies that significantly reduces the royalty burdens associated with current technologies. Internally, Morphotek employs its morphogenics technology to develop optimized therapeutic antibodies for the treatment of cancer, inflammatory and infectious diseases. For further information visit www.morphotek.com.
Dr. Philip M. Sass
Executive Vice President and Chief Operating Officer